Biomet, Inc.: Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensi

Is my product affected?

Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard Product Usage: is indicated for use in

• UPC 00880304462489
• UPC 00880304475458
• UPC 00880304475434

Check against the official notice below — it lists the full affected range.

What happened

Biomet, Inc. is recalling three shoulder replacement components due to potential elevated endotoxin levels exceeding specification limits. The affected products are the Hybrid Glenoid Glenoid Base (4 MM), Comprehensive Reverse Shoulder Humeral Bearing ArComXL (44 MM X 41 MM, Standard), and a third Comprehensive model, with a total of 122 units distributed worldwide across the United States and multiple countries including Canada, India, Japan, Mexico, Netherlands, Singapore, Taiwan, and Thailand. The specific lot numbers affected are 597000, 502510, and 744880.

Elevated endotoxin levels can potentially cause adverse reactions in patients receiving these implants. The recall notice does not specify what remedy or action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Potential presence of elevated endotoxin levels that exceed the specification limit

Details from the source

Reason for recall: Potential presence of elevated endotoxin levels that exceed the specification limit Distribution: Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL. Quantity: 122 units Lot/code info: Lot Numbers: 1)597000 UDI (01)00880304462489(17)211229(10)597000 2) 502510 UDI (01)00880304475458(17)211229(10)502510 3) 744880 UDI (01)00880304475434(17)220117(10)744880

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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